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Contract Manufacturing of HPAPIs with Zero FDA Observations

API Manufacturing >> High Potency APIs (HPAPIs) >> Overview

Manufacturing capabilities from our API plant in Malta. We produce Class 4 HPAPIs with OEL down to 40 ng/m³ within cGMP and FDA inspected environments.

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High Potent Compounds

API Manufacturing >> High Potency APIs (HPAPIs) >> Overview

We perform multi-step synthesis and are experts in handling high potent compounds. cGMP standards are applicable also at this scale.

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Capability to Handle Potent Compounds

API Manufacturing >> High Potency APIs (HPAPIs) >> Overview

Minakem High Potent (MHP) is a recognized world leader custom manufacturer for development and commercialization of Highly Potent APIs (HAPI) requiring production under high containment systems down to OEB class 5, OEL < 0.1 g / m3 / shift.(APIs).

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Achieve Superior Quality With Less Waste

API Manufacturing >> High Potency APIs (HPAPIs) >> Overview

Certified by SafeBridge®, AMRI's facilities provide the most advanced technology for the production and safe containment of your compound.

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High Potency API Synthesis

API Manufacturing >> High Potency APIs (HPAPIs) >> Overview

Pfizer CentreOne specializes in small-molecule API synthesis. We can perform almost any kind of chemistry you need.

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High Potency Active Ingredients Contract Manufacturing

API Manufacturing >> High Potency APIs (HPAPIs) >> Overview

20 years of experience in handling HPAIs according to cGMP, Cerbios is highly qualified in process development and manufacturing of New Chemical Entities with High Potency (High Potency Active Ingredients) characteristics from preclinical to commercial.

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State-of-the-art containment concepts

API Manufacturing >> High Potency APIs (HPAPIs) >> Overview

To handle active substances, DOTTIKON has state-of-the-art containment concepts on all scales (e.g. closed charging/handling/discharging, full protection suit, monitoring, WIP/CIP cleaning, and cleaning validation). These concepts are applied by highly sk

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Production of Non Cytotoxic HPAPIs

API Manufacturing >> High Potency APIs (HPAPIs) >> Overview

Fermion delivers cost-efficient synthesis, process development and life-cycle management solutions to customers within the pharmaceutical value chain to the patient.

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Containment Facilities to Produce Highly Potent APIs

API Manufacturing >> High Potency APIs (HPAPIs) >> Overview

CARBOGEN AMCIS containment facilities are designed based on a containment concept utilizing barrier isolation technology and Rapid Transfer Ports (RTPs) as well as a strict zone concept with pressure cascades, airlocks and access controls.

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cGMP Compliant Highly Potent APIs Production

API Manufacturing >> High Potency APIs (HPAPIs) >> Overview

The Dishman Group offers unparalleled capability in scale-up, development and commercial manufacture of highly potent compounds and vitamins.

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